RepliCel Life Sciences Inc. is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal healing and function. The Companyís product pipeline is comprised of two ongoing clinical trials (RCT-01: tendon repair and RCS-01: skin rejuvenation) as well as its RCH-01: hair restoration product under exclusive license by Shiseido Company for certain Asian countries. All product candidates are based on RepliCelís innovative technology, utilizing cell populations isolated from a patientís healthy hair follicles. The Company has also developed a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications.

"RepliCel Life Sciences Inc. consummated a new strategic alliance in Asia this week, building on the alliance in Japan already in place with Shiseido by adding new China-based partner and equity investor, natural products/consumer products-focused Yofoto Health Industry (private), to its alliance network. . .the impact that the new Yofoto investment has on the company's capital structure is not just transformational but dramatically so."

Japan and the United States are hotspots for companies that are looking to license-out exciting regenerative medicine technology, says Colin Lee Novick, managing director of CJ PARTNERS. In this interview with The Life Sciences Report, Novick discusses a regenerative medicine company pursuing partnerships in Japan for its cell therapies to treat chronic tendinosis, damaged or aged skin, and pattern baldness.

"RepliCel had one clinical trial, Phase 1/2a, for tendon repair in chronic Achilles tendinosis on the RCT-01, a randomized 3:1, double-blind, placebo-controlled trial at the University of British Columbia Sports Medicine Clinic with eight participants. As for final results, the trial met its goal and established a complete safety profile at six months that showed no serious adverse events related to the study treatment or injection procedure. Usually, with the injection, you're going to get some mild irritation, but that's not a large safety issue. It allows RepliCel to proceed to the next stage. But importantly, using a VISA-A scale for Achilles tendon injury severity, the RCT-01 participants had an overall 15.3% improvement in their total score compared to baseline."
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Douglas Loe, Echelon Wealth Partners
(9/13/17)

"RepliCel Life Sciences Inc. announced this morning that it is currently in partnership discussions, with potential partnerships focused not just on the firmís injector, but also on its regenerative medicine therapies. In summary, we remain encouraged by the tangible signals of interest in regards to the geographic distribution of where these discussions are taking place, spanning North America to Europe and more intensely in Asia. . .the update is certainly positive to
the extent it gives us confidence that RepliCel sees the immediate value in expanding its partnership bandwidth in all regenerative medicine markets."

"RepliCel Life Sciences Inc. announced its participation in the
ThawSTAR Early Adopter Program, a cell processing system developed by private CA-based firm Medcision that works with companies in cell therapy processing, for which one of the challenges to sustaining cell viability is managing freeze-thaw cycles. RepliCel will specifically use Medcision's ThawSTAR AT2 Automated Cell Thawing Systems for upcoming Phase II trials using RPís non-bulbar dermal sheath fibroblast therapy RCS-01, aimed at the treatment of skin
rejuvenation (the Phase I trial will be completed this month; interim results reported back in Apr/17)."

SmallCap Network
(4/4/17)

"Replicel Life Sciences Inc. announced statistically and clinically significant positive data from the interim analysis of its phase I study evaluating RCS-01 for the treatment of aging and sun-damaged skin, and the markets are loving the news. . .the study observed the impact of the injection on ten different biomarkers that, in peer-reviewed medical literature, are highly correlated with skin aging and chronically sun-damaged skin. . .gene expression markers, such as tissue inhibitor of metalloproteinases, showed significant changes expected to correlate with increased collagen fibers. Increased collagen production, and reduced collagen degradation, is associated with fewer wrinkles and the repair of sun-damaged skin."

Douglas Loe, Echelon Wealth Partners
(4/4/17)

"RepliCel Life Sciences Inc. reported interim data this morning from its 17-patient Germany-based Phase I trial evaluating impact from its autologous non-bulbar dermal sheath cell (NBDS)-based therapy RCS-01 on biochemical markers of skin rejuvenation. . .clear evidence that RCS-01
up-regulates biochemical pathways that are known to be relevant to skin rejuvenation, as study design intended. . .the trial absolutely met its primary endpoint of demonstrating safety in patients, with no serious adverse events reported at the time of the trial. . .we continue to maintain our Price Target of $3.50."

More Expert Comments

Etienne Moshevich, Alphastox.com(4/4/17)

"RepliCel Life Sciences Inc. is finally in a position to drive substantial growth for shareholders by advancing all three clinical programs as well as continuing to build out their medical device. Management is most likely going to take the month of April to prepare for their next steps in each of their clinical programs and should provide an update once everything is set. . .The streets becoming more bullish on the name as the stock has risen over 30% since its lows last week. . .keep RP.V on your radar screens and keep a very close eye on the story over the next few months."

BioTuesdays Publishing Co.
(4/4/17)

"RepliCel Life Sciences Inc. reported statistically and clinically significant positive data from an interim analysis of its Phase I study evaluating RCS-01 for the treatment of aging and sun-damaged skin."

Zacks Small Cap Research
(4/3/17)

"RepliCel Life Sciences Inc. announced the completion of the Phase 1 study as it successfully met its endpoints. The safety of RCH-01 was demonstrated through measurement of local and systemic tolerance that revealed no serious adverse events reported over the entire 60.5-month follow-up period. . .biopsies performed at 6, 12, and 24 months following injection did not show any evidence of the formation of tumor, granuloma, or foreign body formation. . .The results from the Phase 1 trial show that RCH-01 has a very clean safety profile."

Douglas Loe, Echelon Wealth Partners
(3/28/17)

"We are increasing our RepliCel Life Sciences Inc. price target to $3.50 from $2.15. . .we believe our valuation is conservative when considering how solidly RepliCel has demonstrated functional improvement in at least two cell therapy markets, and with new Achilles tendon repair data serving as evidence for how NBDS could be relevant to other orthopedic/tendon repair markets like rotator cuff injury, or lateral epicondytis or patellar tendinitis, all with similar pathology to Achilles tendinosis. Our model solely values RCT-01 in Achilles tendinosis for now, since that is the only active tendon repair program in RepliCelís pipeline."

James West, Midas Letter(3/27/17)

"RepliCel Life Sciences Inc. recently completed a Phase 1 Clinical Trial that has moved the company that much closer to realizing that goal, and from an investor perspective, the news could not be better. . .RepliCel's attractiveness to the investment community rests on the idea that this is no "one trick pony". Besides male pattern baldness, the company is also advancing a Phase 1/2 trial through Health Canada of its RCT-01 treatment for chronic tendonitis. . .RepliCel's achievements during the first quarter of 2017 places it on a steep trajectory toward commercial success."

Douglas Loe, Echelon Wealth Partners
(3/14/17)

"We are unambiguously positive about what new two-year data suggests about future clinical performance in this [androgenetic alopecia] market, and how it validates RepliCel Life Sciences Inc.ís DSC platform overall. . . RCH- 01 did hit its primary endpoint that was defined mostly by safety and adverse event rate criteria. . .we now have two-year data to show that RCH-01 had a measurable impact on hair density in a sizable proportion of patients, though we will be interested to see on longer-term follow-up."

Shane Matte, BioTuesdays(3/14/17)

"RepliCel Life Sciences Inc. has successfully completed its first-in-human clinical study of the company's autologous cell therapy for the treatment of androgenetic alopecia (pattern baldness). The Phase 1 trial met its endpoints and sets the stage for next steps in ongoing research and development of its product, RCH-01, for the treatment of male and female androgenetic alopecia. . .the five-year trial data set has confirmed the complete safety profile of a high-dose of dermal sheath cup cells (DSCC) for patients with pattern baldness due to androgenetic alopecia. No serious adverse events were reported over the entire 60.5-month follow-up period of the trial."

James Brumley, SmallCap Network
(2/28/17)

"RepliCel Life Sciences Inc., which is working on a trio of aesthetic treatments and one medical device, announced on Tuesday morning it had inked deals with two manufacturers to build some prototypes of the company's planned hardware. Not only is it a sign of progress, for RP investors who looked past the focal point of the press release, the company snuck in a couple of details about the three clinical trials it's also got underway. . .the company is moving more rapidly than perhaps most RP shareholders have expected."

Douglas Loe, Echelon Wealth Partners
(2/28/17)

"RepliCel Life Sciences Inc. announced that it has identified two new two European manufacturers with which it will collaborate going forward on development of its patented Pelletier element cooled dermal injector RCI-02. . .two new manufacturing alliances places dermal injector RCI-02 on track for EU regulatory filing and CE Mark review in 2018. . .the firm formally announced the closing of two separate financings announced in early Feb, cumulatively raising gross proceeds of $3.1M through the sale of 2.53M share-and-warrant units, for which net proceeds to RepliCel of $2.9M solidly reduce financial risk to its ongoing clinical programs."

George Mack, BioDecade
(2/16/17)

"An analyst could show investors the size of these marketsóskin aging, Achilles heel and hair restorationóand any of the three could represent total markets worth billions of dollars. There is an opportunity to carve out hundreds of millions in revenue to produce an extraordinary, eye-opening top line. . .focus on RepliCel Life Sciences Inc.ís current minimalist market cap of under $US20 million and the fact that movement of these clinical studies into phase 2 and phase 3 could mean a very significant increase in share price. RepliCel represents an undiscovered opportunity, but its low market cap precludes mutual funds and pensions from owning it."

Alphastox
(2/12/17)

"RepliCel Life Sciences Inc.'s randomized, placebo-controlled trials in tendon and skin repair will deliver informative data to support the company's story, prioritize future clinical development and guide critical decisions about designing future multi-center clinical trials designed to provide statistically significant clinical data and address questions related to dosing, treatment frequency, etc. . .this is sure to be one of the most exciting stories of 2017 so make sure you stay tuned and keep a very close eye on RepliCel."

BioTuesdays
(2/9/17)

"RepliCel Life Sciences Inc. announced the granting of two patents in Europe related to its multi-needle dermal injection technologies; the first patent has been validated in a total of 14 national countries and the second will also be validated in a number of European countries in the near future. The first device being developed under these patents, RCI-02, is designed for injecting hyaluronic acid and other products as dermal fillers."

"Back in 2013, before the Japanese regenerative medicine laws were promulgated, RepliCel Life Sciences Inc. and Shiseido signed a deal for Replicel's RCH-01 product, which is for androgenic alopecia or male pattern baldness. Shiseido is taking the RCH-01 product down the Act on the Safety of Regenerative Medicine (ASRM) route to market, as they see immense market potential to offer the treatment as quickly as possible to men who suffer from pattern baldness. The ASRM route to market does not come with the coveted Japanese NHI insurance coverage, but the indication is one that doesnít necessarily need the NHI insurance coverage incentive to work. Shiseido already has opened the Shiseido Cell-Processing and Expansion Center (SPEC) in Kobe and is using this location as its base to develop and eventually provide the therapy. Not many non-Japanese companies understand the ASRM route to market but it is one that a relatively well-known regenerative medicine company, Cytori Therapeutics, has already received multiple approvals for over the years and is a very real and relatively fast route to market that exists in Japan. I would keep my eyes peeled on RepliCel and Shiseido in the coming months too for indications as to when the therapy will become available in Japan."
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Zacks Equity Research
(1/24/17)

"RepliCel Life Sciences Inc. secured $4.2 million in cash through the closing of a private placement in October 2016. The offering was actually over-subscribed and included a healthy mix of past, existing, and new investors. . .the lack of funding was a significant overhang for the stock in 2016, but with overhang gone and two major catalysts on the very near-term horizon, this is an incredible opportunity for investors. . .it looks like the recent uptick in the stock is just the beginning for RepliCel."

Zacks Equity Research
(1/24/17)

"One company that looks very well-positioned to benefit from regenerative medicine's rising tide is RepliCel Life Sciences Inc. . .RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions linked to a deficit of healthy cells required for normal healing and function. . .the company's current focus is on the repair of chronically injured tendons, restoration of damaged skin, and the rejuvenation of hair growth.RepliCel is currently engaged in a Phase 1/2 clinical study taking place in Canada examining RCT-01 for the treatment of chronic tendinosis."

Alphastox.com
(1/22/17)

"We've been wildly successful with a couple of our biotech picks, including RepliCel Life Sciences Inc., which is up over 250% in just three months! The company is just starting to get going and I feel we have a ton more room to grow in this deal."

Douglas Loe, Echelon Wealth Partners
(11/2/16)

"RepliCel Life Sciences Inc. reported T4W returns of +49% after announcing the close of the firmís $4.3M private placement. . .performance observed is not just that data point alone; RepliCel is nearing clinical milestones in H216 and H117, specifically with the firmís 10-patient Phase I/II trial, evaluating the autologous non-bulbar dermal sheath cell therapy RCT-01 in patients with Achilles tendinosis. Data from this trial is expected by end of this year. . .a 17-patient skin rejuvenation Phase I/II trial in Germany could release interim sixmonth RCS-01 efficacy data by FQ117."

Douglas Loe, Echelon Wealth Partners
(9/28/16)

"RepliCel Life Sciences Inc. provided two clinical and financial updates. First, the firm announced the intention of settling the firmís debt to certain creditors through the issuance of 719,368 share-and-warrant units. . .second, the firm provided an update on its regulatory activities in Japan, as it concerns partner Shiseido (4911-JP, NR) and the firmís autologous dermal sheath cup cell therapy RCH-01 for androgenetic alopecia. . .the firm noted RCH-01 is currently under clinical investigation at two hospitals, with the trial and the product manufactured by Shiseido. . .the firm notes that early commercialization of the product is possible in Japan."

"I do like RepliCel Life Sciences Inc., a micro-cap, Canadian, regenerative medicine company with a novel technology developing autologous cell therapies. What's interesting about RepliCel is that it has four novel programs on the go, and management has secured a partnership with Shiseido Company in Japan to fund its alopecia trials. RCH-01 for pattern baldness could be on the market in 2018. The company has developed a dermal injector device, RCI-02, to pair with its therapeutic approach. It will file for CE mark approval of the dermal injector in the European Union (EU) later this year, and I think the product will be on the market in Europe in 2017. Management has been able to derisk this little company in a way many small companies haven't been able to do. . .[the dermal injector] is a novel instrument with extreme precision that sources the cells in the scalp. It has an analgesic delivery capability built in so it can simultaneously anesthetize the skin and obtain autologous dermal sheath cells. It will have many applications. . .RepliCel won't market the product itself, but will partner that out. The company could have the alopecia therapy on the market in Japan in 2018, and the dermal injector could be on the market in the EU in 2017. . .the device is a catalyst. Even though RepliCel will have data in the alopecia and tendon repair indications later this year, I think dermal injector may carry more weight because the market may realize it represents the fastest route to commercialization and revenues, which would help the company mitigate some of its cash burn. The adoption and costs to market the device are much less than they would be for developing and commercializing a therapeutic."
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